Prognostic ability of FRAIL-NH for mortality in institutionalized older Japanese adults: a 1-year prospective observational study of the KITAKAWACHI study

Prognostic ability of FRAIL-NH for mortality in institutionalized older Japanese adults: a 1-year prospective observational study of the KITAKAWACHI study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Prognostic ability of FRAIL-NH for mortality in institutionalized older Japanese adults: a 1-year prospective observational study of the KITAKAWACHI study Eriko Nakata, Eri Nishioka, Nagomi Ito, Nana Yunoki, Hirokazu Oyamada, and 14 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5978015/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The present study aimed to investigate the predictive ability of the FRAIL-NH scale for 1-year mortality in institutionalized older Japanese patients and the determine the cutoff value. Methods This prospective observational study used data from the KITAKAWACHI study, which commenced in October 2021. The analysis included baseline data from September 2021 to January 2022 and 1-year follow-up data from September 2022 to January 2023. In total, 227 institutionalized older patients were included in the analysis, with those who died within 1 year categorized into the Died group and the other patients included in the Alive group. Receiver operating characteristic analysis was used to examine the ability and cut-off value of FRAIL-NH for predicting 1-year mortality. Results Thirty-three patients (14.5%) died within 1 year, and there were significantly more patients with a high level of nursing care, low body mass index, lower calf circumference, malnutrition, and dysphagia. In addition, there were 117 (51.5%) cases of frailty, and the mortality rate was significantly higher in the Died group than that in the Alive group based on the FRAIL-NH score (8.0 [7.0, 9.5] vs. 5.0 [2.0, 7.0]) and all components, except illness, and the percentage of frailties. Furthermore, receiver operating characteristics analysis for 1-year mortality yielded an area under the curve (95% confidence interval) of 0.806 (0.729–0.883) and a cutoff value of 6.5 points for the FRAIL-NH based on the Youden's index. The sensitivity, specificity, false-positive rate, false-negative rate, and accuracy of the 7-point cutoff (the approximated value of the 6.5-point cutoff) were 84.8%, 70.6%, 15.2%, 29.4%, and 72.7%, respectively, which were more balanced in sensitivity and specificity than the 6- and 8-point cutoffs reported in previous studies, with intermediate false-positive rate, false-negative rate, and accuracy. Conclusions The FRAIL-NH scale predicted the risk of 1-year mortality in institutionalized older Japanese adults. When FRAIL-NH was used in nursing homes, a cutoff value of 7 points appeared to be the best predictor of outcomes. These findings highlight the critical role of early frailty screening in improving patient care and decision-making in geriatric care settings. nursing homes frailty ROC curve mortality FRAIL-NH Figures Figure 1 Figure 2 Background Frailty is a significant risk factor for mortality in institutionalized older patients, and it is necessary to appropriately assess and manage frailty status [ 1 ]. The Japanese version of the Cardiovascular Health Study criteria (J-CHS criteria) [ 2 ] and Kihon checklist [ 3 ] are often used to assess frailty in independent community-dwelling older adults. However, these questionnaires are based on Fried’ phenotype model and unsuitable for institutionalized older patients requiring care. The FRAIL-NH scale was developed as an index to evaluate frailty (deficit accumulation model) in institutionalized older patients [ 4 ]. The FRAIL-NH scale has been previously validated in the assessment of frailty in institutionalized older patients in Western countries, and its usefulness for predicting prognosis has been reported [ 5 – 7 ]. Sakata et al was reported that a Japanese version of the FRAIL-NH translated from its original version [ 8 ]. Among studies using the FRAIL-NH in institutionalized older patients, one study investigated the use of symptomatic and prophylactic drugs, based on age and frailty status, in nursing homes in Japan and Australia [ 9 ]; in addition, another study compared the prevalence of STOPPFrail drugs according to frailty status in residents of nursing home in Japan, Australia, China, and Spain [ 10 ]. We conducted a multi-center evaluation using the FRAIL-NH scale in institutionalized older Japanese patients; the proportion of participants with frailty was 49.5%, and choking/residue and concentration problems were significantly related to frailty [ 11 ]. However, the prognostic and cutoff values of the FRAIL-NH scale in Japan have not yet been established. The validation of the prognostic ability of the FRAIL-NH scale will lead to the early detection of frailty in institutionalized older patients, improve efforts to prevent the deterioration of frailty, ensure appropriate nursing care support, and facilitate the prognosis of longevity. Therefore, his study aimed to examine the predictive validity of the FRAIL-NH scale for 1-year mortality in institutionalized older Japanese patients and the cutoff value of the scale. Methods Study design and participants This prospective observational study used data from the KITAKAWACHI study, which commenced in October 2021. The KITAKAWACHI study is a 4-year, multi-center, prospective observational study to identify factors contributing to frailty in institutionalized older patients. This study is a questionnaire survey using items that are routinely evaluated . Questionnaires were distributed to five institutions (three nursing homes and two Long-term care (LTC) facilities) in the Kitakawachi area of Osaka Prefecture, Japan. 294 participants, all residents of each facility, at the beginning of the study were enrolled. In the present study, we used baseline data from September 2021 to January 2022 and 1-year follow-up data from September 2022 to January 2023. The sample size was calculated using G*Power 3.1.9.2 (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) according to the method of Ito et al [ 11 ]. Based on an effect size 0.5, an α error 0.05, a power of 0.8, an allocation ratio of 0.6 [ 12 – 13 ], the required sample size was calculated to be 336 patients (Group 1, n = 85; Group 2, n = 251). Figure 1 shows a flowchart of the study protocol. Of the 294 participants, we excluded two participants under 65 years of age and 63 patients for whom the FRAIL-NH score could not be calculated because of missing data; ultimately, 229 patients were included in the follow-up. At the 1-year follow-up, two patients with unknown survival status were excluded; finally, 227 participants were included in the final analysis (77.4% follow-up). This study was performed in accordance with the Declaration of Helsinki and approved by the Research Ethics Committee of the Graduate School of Human Life Science, Osaka City University (approval number: 21–29). Facility directors consented to this study, and an opt-out process was used to inform the patients and their surrogates about our investigation. Questionnaire In the present the study, the research director developed a questionnaire that integrated the following survey items: participant characteristics (sex, age, height, weight, body mass index [BMI]), calf circumference, main disease, number of medications (< 5, 5–9, ≥ 10), swallowing function, frailty status, nutritional status, comorbidity and functional status. Registered dietitians (the investigator) at each institution completed the questionnaire. Before the survey, the research directors explained the purpose of the study, survey items and methods to the investigators at each site. In addition, a manual containing notes on the evaluation items was distributed. All measurements were performed to the maximum extent possible, depending on the participant's physical disability and cognitive status. Annually, follow-up questionnaires were mailed to each facility. After filling in the information for all participants at each institution were completed, the investigators were instructed to return the completed questionnaires to the research director. Swallowing function The Seirei Swallowing Questionnaire was used to evaluate swallowing function [ 14 ]. The questionnaire was developed for easy applicability in clinical practice and consists of 15 swallowing function-related items, with scores assigned on a three-level scale: A, severe symptoms (4 points); B, mild symptoms (1 point); and C, no symptoms (0 points). In a previous study, when participants with ≥ 8 points were evaluated as having suspected dysphagia, the sensitivity and specificity of the questionnaire were 90.0% and 89.8%, respectively [ 15 ]. Therefore, we defined ≥ 8 points as indicative of dysphagia. Nutritional status We assessed the nutritional status of the participants using the MNA-SF [ 16 ]. The participants were classified as malnourished (0–7 points), at risk of malnutrition (8–11 points), or well-nourished (12–14 points) based on their total score. Comorbidities and functional status The severity of comorbidities among the participants was assessed using the Charlson Comorbidity Index (CCI) [ 17 ]. We classified patients into four groups based on their CCI scores: low (0 points), medium (1–2 points), high (3–4 points), and very high (≥ 5 points). The care-need level was assessed using a standardized process conducted by a trained local government official under the Japanese LTC insurance system. The details of the system have been described previously [ 18 ]. In brief, there are five care-need levels, ranging from the mildest (care-need level 1) to the most severe (care-need level 5), which determine the amount and type of care services and benefits individuals can receive. In Japan, LTC facilities are occupied by individuals with care-need levels 1–5, whereas nursing homes are typically occupied by individuals with care-need levels 3–5. The participants’ levels of independence in ADL were evaluated using the degree of independence in daily living (DIDL) of older individuals with dementia and disabilities [ 19 ]. The DIDL was defined by the Japanese Ministry of Health, Labor, and Welfare, and it assesses dementia severity based on communication difficulties and symptoms or behaviors due to dementia and evaluates disability based on mobility. In accordance with previous studies [ 20 , 21 ], we categorized the DIDL of older individuals with dementia into two categories: normal/rank 1/2 (indicating the ability to live independently) and rank 3/4/M (indicating interference with daily living and the need for nursing care). The DIDL of the older individuals with disabilities were categorized into three groups: (1) independent, (2) mildly dependent, and (3) severely dependent. Frailty status The Japanese version of the FRAIL-NH [ 8 ], with confirmed linguistic validity, was used to assess frailty at baseline. The FRAIL-NH scale consists of seven domains (Malaise, transfer, mobility, incontinence or illness, weight loss, nutrition/diet and dressing), each with a score of 0–2 points. The total FRAIL-NH score is 0–14 points; the higher the FRAIL-NH score, the worse the score. In the present study, illness (number of drugs used [< 5 = 0 point, 5–9 = 1 point, < 10 = 2 points]) was used to evaluate. In this study, frailty was defined as a FRAIL-NH score of 6 or more [ 12 ]. Outcome The study outcome was death within 1 year. The 1-year follow-up survey was performed using a questionnaire assessing survival status. The investigator selected the status of each participant after 1 year from three categories: “Still in the facility,” “Leaving the facility,” and “Other.” If the participant had died within 1 year, “Other” was selected and “Death’ was entered. Among the participants who left the facility, those whose reason for leaving was hospitalization were asked to record their current survival status. Based on these findings, patients who died during follow-up and those who were discharged because of hospitalization were divided into two groups: the Died (those who died during hospitalization) and Alive groups (others). Statistical analysis All statistical analyses were performed using IBM SPSS Statistics ver. 25.0 (IBM Corp., Armonk, NY, USA). Quantitative variables are presented as means ± standard deviation or medians (interquartile range; IQR). The unpaired t-test or Mann–Whitney U test was used to compare quantitative variables between the two groups. Qualitative variables were compared using Fisher's exact or chi-square test. To investigate whether FRAIL-NH was a significant predictor of mortality, receiver operating characteristic (ROC) analysis was performed, and a statistical cutoff value was calculated using the Youden’s index. The area under the ROC curve (AUC) and 95% confidence interval (CI) were calculated to confirm the predictive and diagnostic performance of the ROC analysis. Furthermore, assuming the use of the FRAIL-NH in nursing care settings, we compared the sensitivity, specificity, false-positive rate, false-negative rate, and accuracy rate of the FRAIL-NH scale using an integer value that approximated the cutoff value obtained from ROC analysis and determined the most valid cutoff value. All analyses were two-sided, with a significance level ˂5%. Results Characteristics Table 1 presents the results of the comparison of the baseline characteristics of the study participants. Of 227 participants included in the analysis, 33 (14.5%) died within 1 year; the mean age at baseline was 87.3 ± 6.3 years (year range; 70–102 years) and 171 participants (75.3%) were women. Compared to the Alive group, the Died group had significantly higher levels of nursing care and lower BMI and calf circumference. In addition, more patients had malnutrition and dysphagia in the Died group. Comparison of the FRAIL-NH scores and its components Table 2 shows the comparison of the baseline FRAIL-NH scores and the scale’s components. The median FRAIL-NH score of all participants was 6.0 (3.0, 8.0) points, and 117 participants (51.5%) were judged frail. Compared to the Alive group, the Died group had a significantly higher FRAIL-NH score (8.0 [7.0, 9.5] vs. 5.0 [2.0, 7.0]) for all components, except illness, and a significantly higher percentage of patients rated as frail. Validation of the FRAIL-NH cutoff for mortality Figure 2 and Table 3 show the statistical cutoff values obtained using the ROC analysis, along with their sensitivity, specificity, and 1-specificity. The AUC (95% CI) was 0.806 (0.729–0.883). The cutoff value for FRAIL-NH, calculated based on the Youden's index was 6.5 points. Table 4 shows the calculated sensitivity, specificity, false-positive rate, false-negative rate, and accuracy for FRAIL-NH cutoff value of 7 points (the approximated value of the cutoff value of 6.5 points obtained via the ROC analysis) and 6 and 8 points reported in previous studies. The sensitivity, specificity, false-positive, false-negative, and accuracy rates of the 7-point cutoff were 84.8%, 70.6%, 15.2%, 29.4%, and 72.7%, respectively, which were more balanced in sensitivity and specificity than the 6- and 8-point cutoffs, with intermediate false-positive, false-negative, and accuracy rates. Discussion The results of this study showed that the FRAIL-NH scale predicted 1-year mortality in institutionalized older Japanese patients, with a cutoff value of 6.5 points. Furthermore, when the use of the FRAIL-NH scale was assumed in nursing homes, 7 points was considered the most appropriate integer cutoff value. Although several previous studies have examined the predictive ability of frailty assessed using the FRAIL-NH for 1-year mortality, the cutoff values ranged from 2 [ 22 ] to 6 points [ 12 , 23 , 24 ], and no reference cutoff value has been established. In the present study, ROC analysis suggested a statistical cutoff of 6.5 points for predicting 1-year mortality risk. In addition, we assumed the actual use of FRAIL-NH in nursing homes and considered the most valid cutoff value to be 7, which is an integer close to the statistical cutoff value of 6.5, obtained using ROC analysis, and 6 and 8 points (previously used as diagnostic criteria for frailty). The false-positive and false-negative rates with of the 7-point cut-off were better maintained than those of the 6- and 8-point cutoffs. In the prospective cohort of Luo et al [ 25 ], a significant HR of 2.76 (2.13–3.57) for the risk of death was also reported when the FRAIL-NH cut-off point was 7 points, and this study supports previous studies. However, when the cutoff values of 6 [ 12 , 24 ] and 8 points [ 7 , 26 ] for predicting 1-year mortality in previous studies were applied in the present study, the sensitivity and specificity were low, the prognosis was considered to be less accurate. Therefore, a 7-point FRAIL-NH cutoff for 1-year mortality prediction in institutionalized older Japanese patients seems to be the most appropriate. Buckinx et al [ 27 ] and Contreras-Escámez et al [ 28 ] reported that the FRAIL-NH scale had no predictive ability for 1-year mortality. In a large cohort study of institutionalized older Japanese patients [ 29 ], the 1-year mortality rate was 12.7%, compared to 14.5% reported in the present study. Notably, the patients in the present study were similar to those in a previous study; however, the fact that the participants in the present study were somewhat older and largely residents of special nursing homes with a higher level of nursing care may have affected the results. In the future, it will be necessary to determine the most appropriate cutoff value of the FRAIL-NH scale for Japanese patients using a wider longitudinal study. The present study had some limitations. First, although the investigators at each facility were instructed about the contents of the survey items, there were differences among the evaluators. Second, the survey was conducted in a limited area with a small sample size, and it is unclear whether similar results can be obtained for older patients in nursing homes in other areas. Therefore, reproducibility in different populations needs to be verified. However, this is the first multicenter study to determine the predictive validity of the 1-year mortality risk using the FRAIL-NH scale in institutionalized older Japanese patients. In addition, we examined in detail the most effective cutoff value for predicting Japanese-specific mortality using the FRAIL-NH scale in nursing care settings. In the future, it will be necessary to examine the prognostic validity of the FRAIL-NH cutoff value of 7 points after adjusting for confounding factors of mortality in institutionalized older Japanese patients. Conclusion The study showed that the FRAIL-NH scale has predictive validity for 1-year mortality rate in institutionalized older Japanese patients. When the FRAIL-NH is used in nursing homes, a cutoff value of 7 points appears to be the best predictor of outcomes. Declarations Ethics approval and consent to participate This study complied with the Declaration of Helsinki and was approved by the Research Ethics Committee of the Graduate School of Human Life Science, Osaka City University (approval number 21-29). Facility directors consented this study, and an optout process was used to inform residents and their surrogates about our study. Consent for publication Not applicable. Availability of data and materials The datasets generated and/or analyzed during the present study are not publicly available. Data are available from the corresponding author upon request. Competing interests The authors declare that they have no competing interests. Funding Not applicable. Authors’ contributions Study conception and design: Eri Nishioka and Chika Momoki; Acquisition: Eri Nishioka, Nagomi Ito, Nana Yunoki, Hirokazu Oyamada, Yoko Urata, Harumi Imura, Jun Ookita, Seiko Wada, Masashi Futamata, Sachiyo Kam, Noriko Wajima, Chizuru Takatori, Michiko Tabata, Eri Shibata, Hirotsugu Ishida, Jyunko Masuo; Acquisition, analysis, and interpretation: Eriko Nakata and Chika Momoki; Critical revision: Daiki Habu. All persons designated as authors qualify for authorship, and all authors have been listed. Each author participated sufficiently in the work to take public responsibility for appropriate portions of the manuscript. All the authors have read and approved the final version of the manuscript. Acknowledgements We would like to express our deepest gratitude to all nursing home staff and patients for their cooperation in this research. We would like to thank Honyaku Center Inc.for English language editing. 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Nakazawa A, Nakamura K, Kitamura K, Yoshizawa Y. Association between body mass index and mortality among institutionalized elderly adults in Japan. Environ Health Prev Med. 2013;18:502–6. Tables Table 1 to 4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files KITAKAWACHIstudyTables.xlsx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5978015","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":415807653,"identity":"a9416ec7-ced9-4fe9-974a-c29dd8bf8ca1","order_by":0,"name":"Eriko Nakata","email":"","orcid":"","institution":"Setsunan University","correspondingAuthor":false,"prefix":"","firstName":"Eriko","middleName":"","lastName":"Nakata","suffix":""},{"id":415807654,"identity":"81ec02d9-2f92-4fba-bc78-3739251cc542","order_by":1,"name":"Eri Nishioka","email":"","orcid":"","institution":"Osaka Metropolitan 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NOZOMI","correspondingAuthor":false,"prefix":"","firstName":"Sachiyo","middleName":"","lastName":"Kami","suffix":""},{"id":415807664,"identity":"a22e4171-cea1-4de4-9446-6a5475969079","order_by":11,"name":"Noriko Wajima","email":"","orcid":"","institution":"Small-Scale Special Nursing Home NOZOMI","correspondingAuthor":false,"prefix":"","firstName":"Noriko","middleName":"","lastName":"Wajima","suffix":""},{"id":415807665,"identity":"fc545cc3-d34e-4452-880e-1c867bad2086","order_by":12,"name":"Chizuru Takatori","email":"","orcid":"","institution":"Long-Term Care Health Facility NOZOMI","correspondingAuthor":false,"prefix":"","firstName":"Chizuru","middleName":"","lastName":"Takatori","suffix":""},{"id":415807666,"identity":"d37bdcaf-4b3c-4447-bba1-74d4676d0f08","order_by":13,"name":"Michiko Tabata","email":"","orcid":"","institution":"Long-Term Care Health Facility 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YUMEGOKORO","correspondingAuthor":false,"prefix":"","firstName":"Jyunko","middleName":"","lastName":"Masuo","suffix":""},{"id":415807670,"identity":"c3bc66f4-801a-4627-b384-e63bd73b492c","order_by":17,"name":"Daiki Habu","email":"","orcid":"","institution":"Osaka Metropolitan University","correspondingAuthor":false,"prefix":"","firstName":"Daiki","middleName":"","lastName":"Habu","suffix":""},{"id":415807671,"identity":"1482b6dc-8700-4e1f-b9dc-e148ec23328e","order_by":18,"name":"Chika Momoki","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABEElEQVRIiWNgGAWjYDACCcZmKIuN4cAHVLkDhLUcnAHkE6GFgRmuhZkHVQt2wD+7udngB8M2Od32tsTDNn9s6uRn5B78XMBgJ8/AeBarNRJ3DjYn9jDcNjY7c+zA4dy2NAmDG3nJ0jMYkg0bGM4lYNNiIJHYfICH4XbithvpDYdzGw5LGEjkGEjzMDADlZ8xwKXl4B+YFos//yXkZ+QY/+ZhqMerJRliS9qBwwxsByQYbuSYAW05jFOLxI3EZmMZA7BfEg72tiVLbjjzxsyax+C4YRsOv/DPSH8s+abitpzZ8TbjDz/+2PHLt+cY3+apqJbnl8AeYlDnYRNhkziDWwcOwN9DspZRMApGwSgYlgAAIixiQ3fP7pcAAAAASUVORK5CYII=","orcid":"","institution":"Setsunan University","correspondingAuthor":true,"prefix":"","firstName":"Chika","middleName":"","lastName":"Momoki","suffix":""}],"badges":[],"createdAt":"2025-02-07 05:38:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5978015/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5978015/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":76578106,"identity":"b8878c66-4423-4abe-b4fc-36e3096b4e62","added_by":"auto","created_at":"2025-02-18 14:34:57","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":28447,"visible":true,"origin":"","legend":"\u003cp\u003eParticipant flow\u003c/p\u003e","description":"","filename":"KITAKAWACHIstudyfigure1.png","url":"https://assets-eu.researchsquare.com/files/rs-5978015/v1/ff328d46502065a29d679a6d.png"},{"id":76577911,"identity":"276d58ae-1878-44fa-9f5b-dddfcba32721","added_by":"auto","created_at":"2025-02-18 14:26:57","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":40659,"visible":true,"origin":"","legend":"\u003cp\u003eFRAIL-NH cutoff for mortality\u003c/p\u003e","description":"","filename":"KITAKAWACHIstudyfigure2.png","url":"https://assets-eu.researchsquare.com/files/rs-5978015/v1/b5edb63881dfdce4b8c71fff.png"},{"id":106597672,"identity":"31f76eec-05eb-403a-b011-6fe5c252b356","added_by":"auto","created_at":"2026-04-10 09:43:12","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":713689,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5978015/v1/a75e71bf-c486-4afd-a054-84497e2efe4a.pdf"},{"id":76577915,"identity":"1b8334ab-344d-493a-bd5a-81c491d9a5f1","added_by":"auto","created_at":"2025-02-18 14:26:57","extension":"xlsx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":35800,"visible":true,"origin":"","legend":"","description":"","filename":"KITAKAWACHIstudyTables.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-5978015/v1/130f50c424f3159d9673832c.xlsx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Prognostic ability of FRAIL-NH for mortality in institutionalized older Japanese adults: a 1-year prospective observational study of the KITAKAWACHI study","fulltext":[{"header":"Background","content":"\u003cp\u003eFrailty is a significant risk factor for mortality in institutionalized older patients, and it is necessary to appropriately assess and manage frailty status [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The Japanese version of the Cardiovascular Health Study criteria (J-CHS criteria) [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] and Kihon checklist [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] are often used to assess frailty in independent community-dwelling older adults. However, these questionnaires are based on Fried\u0026rsquo; phenotype model and unsuitable for institutionalized older patients requiring care.\u003c/p\u003e \u003cp\u003eThe FRAIL-NH scale was developed as an index to evaluate frailty (deficit accumulation model) in institutionalized older patients [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The FRAIL-NH scale has been previously validated in the assessment of frailty in institutionalized older patients in Western countries, and its usefulness for predicting prognosis has been reported [\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Sakata et al was reported that a Japanese version of the FRAIL-NH translated from its original version [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Among studies using the FRAIL-NH in institutionalized older patients, one study investigated the use of symptomatic and prophylactic drugs, based on age and frailty status, in nursing homes in Japan and Australia [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]; in addition, another study compared the prevalence of STOPPFrail drugs according to frailty status in residents of nursing home in Japan, Australia, China, and Spain [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. We conducted a multi-center evaluation using the FRAIL-NH scale in institutionalized older Japanese patients; the proportion of participants with frailty was 49.5%, and choking/residue and concentration problems were significantly related to frailty [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. However, the prognostic and cutoff values of the FRAIL-NH scale in Japan have not yet been established. The validation of the prognostic ability of the FRAIL-NH scale will lead to the early detection of frailty in institutionalized older patients, improve efforts to prevent the deterioration of frailty, ensure appropriate nursing care support, and facilitate the prognosis of longevity.\u003c/p\u003e \u003cp\u003eTherefore, his study aimed to examine the predictive validity of the FRAIL-NH scale for 1-year mortality in institutionalized older Japanese patients and the cutoff value of the scale.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and participants\u003c/h2\u003e \u003cp\u003eThis prospective \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eobservational\u003c/span\u003e study used data from the KITAKAWACHI study, which commenced in October 2021. The KITAKAWACHI study is a 4-year, multi-center, prospective \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eobservational\u003c/span\u003e study to identify factors contributing to frailty in institutionalized older patients. \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eThis study is a questionnaire survey using items that are routinely evaluated\u003c/span\u003e. Questionnaires were distributed to five institutions (three nursing homes and two Long-term care (LTC) facilities) in the Kitakawachi area of Osaka Prefecture, Japan. 294 participants, all residents of each facility, at the beginning of the study were enrolled. In the present study, we used baseline data from September 2021 to January 2022 and 1-year follow-up data from September 2022 to January 2023.\u003c/p\u003e \u003cp\u003eThe sample size was calculated using G*Power 3.1.9.2 (Heinrich-Heine-Universit\u0026auml;t D\u0026uuml;sseldorf, D\u0026uuml;sseldorf, Germany) according to the method of Ito et al [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Based on an effect size 0.5, an α error 0.05, a power of 0.8, an allocation ratio of 0.6 [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], the required sample size was calculated to be 336 patients (Group 1, n\u0026thinsp;=\u0026thinsp;85; Group 2, n\u0026thinsp;=\u0026thinsp;251).\u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows a flowchart of the study protocol. Of the 294 participants, we excluded two participants under 65 years of age and 63 patients for whom the FRAIL-NH score could not be calculated because of missing data; ultimately, 229 patients were included in the follow-up. At the 1-year follow-up, two patients with unknown survival status were excluded; finally, 227 participants were included in the final analysis (77.4% follow-up).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e This study was performed in accordance with the Declaration of Helsinki and approved by the Research Ethics Committee of the Graduate School of Human Life Science, Osaka City University (approval number: 21\u0026ndash;29). Facility directors consented to this study, and an opt-out process was used to inform the patients and their surrogates about our investigation.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eQuestionnaire\u003c/h3\u003e\n\u003cp\u003eIn the present the study, the research director developed a questionnaire that integrated the following survey items: participant characteristics (sex, age, height, weight, body mass index [BMI]), calf circumference, main disease, number of medications (\u0026lt;\u0026thinsp;5, 5\u0026ndash;9, \u0026ge;\u0026thinsp;10), swallowing function, frailty status, nutritional status, comorbidity and functional status. Registered dietitians (the investigator) at each institution completed the questionnaire. Before the survey, the research directors explained the purpose of the study, survey items and methods to the investigators at each site. In addition, a manual containing notes on the evaluation items was distributed. All measurements were performed to the maximum extent possible, depending on the participant's physical disability and cognitive status. Annually, follow-up questionnaires were mailed to each facility. After filling in the information for all participants at each institution were completed, the investigators were instructed to return the completed questionnaires to the research director.\u003c/p\u003e\n\u003ch3\u003eSwallowing function\u003c/h3\u003e\n\u003cp\u003eThe Seirei Swallowing Questionnaire was used to evaluate swallowing function [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The questionnaire was developed for easy applicability in clinical practice and consists of 15 swallowing function-related items, with scores assigned on a three-level scale: A, severe symptoms (4 points); B, mild symptoms (1 point); and C, no symptoms (0 points). In a previous study, when participants with \u0026ge;\u0026thinsp;8 points were evaluated as having suspected dysphagia, the sensitivity and specificity of the questionnaire were 90.0% and 89.8%, respectively [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Therefore, we defined\u0026thinsp;\u0026ge;\u0026thinsp;8 points as indicative of dysphagia.\u003c/p\u003e\n\u003ch3\u003eNutritional status\u003c/h3\u003e\n\u003cp\u003eWe assessed the nutritional status of the participants using the MNA-SF [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The participants were classified as malnourished (0\u0026ndash;7 points), at risk of malnutrition (8\u0026ndash;11 points), or well-nourished (12\u0026ndash;14 points) based on their total score.\u003c/p\u003e\n\u003ch3\u003eComorbidities and functional status\u003c/h3\u003e\n\u003cp\u003eThe severity of comorbidities among the participants was assessed using the Charlson Comorbidity Index (CCI) [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. We classified patients into four groups based on their CCI scores: low (0 points), medium (1\u0026ndash;2 points), high (3\u0026ndash;4 points), and very high (\u0026ge;\u0026thinsp;5 points).\u003c/p\u003e \u003cp\u003eThe care-need level was assessed using a standardized process conducted by a trained local government official under the Japanese LTC insurance system. The details of the system have been described previously [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. In brief, there are five care-need levels, ranging from the mildest (care-need level 1) to the most severe (care-need level 5), which determine the amount and type of care services and benefits individuals can receive. In Japan, LTC facilities are occupied by individuals with care-need levels 1\u0026ndash;5, whereas nursing homes are typically occupied by individuals with care-need levels 3\u0026ndash;5.\u003c/p\u003e \u003cp\u003eThe participants\u0026rsquo; levels of independence in ADL were evaluated using the degree of independence in daily living (DIDL) of older individuals with dementia and disabilities [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The DIDL was defined by the Japanese Ministry of Health, Labor, and Welfare, and it assesses dementia severity based on communication difficulties and symptoms or behaviors due to dementia and evaluates disability based on mobility. In accordance with previous studies [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], we categorized the DIDL of older individuals with dementia into two categories: normal/rank 1/2 (indicating the ability to live independently) and rank 3/4/M (indicating interference with daily living and the need for nursing care). The DIDL of the older individuals with disabilities were categorized into three groups: (1) independent, (2) mildly dependent, and (3) severely dependent.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eFrailty status\u003c/h2\u003e \u003cp\u003eThe Japanese version of the FRAIL-NH [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], with confirmed linguistic validity, was used to assess frailty at baseline. The FRAIL-NH scale consists of seven domains (Malaise, transfer, mobility, incontinence or illness, weight loss, nutrition/diet and dressing), each with a score of 0\u0026ndash;2 points. The total FRAIL-NH score is 0\u0026ndash;14 points; the higher the FRAIL-NH score, the worse the score. In the present study, illness (number of drugs used [\u0026lt;\u0026thinsp;5\u0026thinsp;=\u0026thinsp;0 point, 5\u0026ndash;9\u0026thinsp;=\u0026thinsp;1 point, \u0026lt;\u0026thinsp;10\u0026thinsp;=\u0026thinsp;2 points]) was used to evaluate. In this study, frailty was defined as a FRAIL-NH score of 6 or more [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOutcome\u003c/h3\u003e\n\u003cp\u003eThe study outcome was death within 1 year. The 1-year follow-up survey was performed using a questionnaire assessing survival status. The investigator selected the status of each participant after 1 year from three categories: \u0026ldquo;Still in the facility,\u0026rdquo; \u0026ldquo;Leaving the facility,\u0026rdquo; and \u0026ldquo;Other.\u0026rdquo; If the participant had died within 1 year, \u0026ldquo;Other\u0026rdquo; was selected and \u0026ldquo;Death\u0026rsquo; was entered. Among the participants who left the facility, those whose reason for leaving was hospitalization were asked to record their current survival status. Based on these findings, patients who died during follow-up and those who were discharged because of hospitalization were divided into two groups: the Died (those who died during hospitalization) and Alive groups (others).\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll statistical analyses were performed using IBM SPSS Statistics ver. 25.0 (IBM Corp., Armonk, NY, USA). Quantitative variables are presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or medians (interquartile range; IQR). The unpaired t-test or Mann\u0026ndash;Whitney U test was used to compare quantitative variables between the two groups. Qualitative variables were compared using Fisher's exact or chi-square test. To investigate whether FRAIL-NH was a significant predictor of mortality, receiver operating characteristic (ROC) analysis was performed, and a statistical cutoff value was calculated using the Youden\u0026rsquo;s index. The area under the ROC curve (AUC) and 95% confidence interval (CI) were calculated to confirm the predictive and diagnostic performance of the ROC analysis. Furthermore, assuming the use of the FRAIL-NH in nursing care settings, we compared the sensitivity, specificity, false-positive rate, false-negative rate, and accuracy rate of the FRAIL-NH scale using an integer value that approximated the cutoff value obtained from ROC analysis and determined the most valid cutoff value. All analyses were two-sided, with a significance level ˂5%.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;1 presents the results of the comparison of the baseline characteristics of the study participants. Of 227 participants included in the analysis, 33 (14.5%) died within 1 year; the mean age at baseline was 87.3\u0026thinsp;\u0026plusmn;\u0026thinsp;6.3 years (year range; 70\u0026ndash;102 years) and 171 participants (75.3%) were women. Compared to the Alive group, the Died group had significantly higher levels of nursing care and lower BMI and calf circumference. In addition, more patients had malnutrition and dysphagia in the Died group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eComparison of the FRAIL-NH scores and its components\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;2 shows the comparison of the baseline FRAIL-NH scores and the scale\u0026rsquo;s components. The median FRAIL-NH score of all participants was 6.0 (3.0, 8.0) points, and 117 participants (51.5%) were judged frail. Compared to the Alive group, the Died group had a significantly higher FRAIL-NH score (8.0 [7.0, 9.5] vs. 5.0 [2.0, 7.0]) for all components, except illness, and a significantly higher percentage of patients rated as frail.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eValidation of the FRAIL-NH cutoff for mortality\u003c/h2\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and Table\u0026nbsp;3 show the statistical cutoff values obtained using the ROC analysis, along with their sensitivity, specificity, and 1-specificity. The AUC (95% CI) was 0.806 (0.729\u0026ndash;0.883). The cutoff value for FRAIL-NH, calculated based on the Youden's index was 6.5 points.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;4 shows the calculated sensitivity, specificity, false-positive rate, false-negative rate, and accuracy for FRAIL-NH cutoff value of 7 points (the approximated value of the cutoff value of 6.5 points obtained via the ROC analysis) and 6 and 8 points reported in previous studies. The sensitivity, specificity, false-positive, false-negative, and accuracy rates of the 7-point cutoff were 84.8%, 70.6%, 15.2%, 29.4%, and 72.7%, respectively, which were more balanced in sensitivity and specificity than the 6- and 8-point cutoffs, with intermediate false-positive, false-negative, and accuracy rates.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe results of this study showed that the FRAIL-NH scale predicted 1-year mortality in institutionalized older Japanese patients, with a cutoff value of 6.5 points. Furthermore, when the use of the FRAIL-NH scale was assumed in nursing homes, 7 points was considered the most appropriate integer cutoff value.\u003c/p\u003e \u003cp\u003eAlthough several previous studies have examined the predictive ability of frailty assessed using the FRAIL-NH for 1-year mortality, the cutoff values ranged from 2 [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] to 6 points [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e], and no reference cutoff value has been established. In the present study, ROC analysis suggested a statistical cutoff of 6.5 points for predicting 1-year mortality risk.\u003c/p\u003e \u003cp\u003eIn addition, we assumed the actual use of FRAIL-NH in nursing homes and considered the most valid cutoff value to be 7, which is an integer close to the statistical cutoff value of 6.5, obtained using ROC analysis, and 6 and 8 points (previously used as diagnostic criteria for frailty). The false-positive and false-negative rates with of the 7-point cut-off were better maintained than those of the 6- and 8-point cutoffs. In the prospective cohort of Luo et al [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], a significant HR of 2.76 (2.13\u0026ndash;3.57) for the risk of death was also reported when the FRAIL-NH cut-off point was 7 points, and this study supports previous studies.\u003c/p\u003e \u003cp\u003eHowever, when the cutoff values of 6 [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] and 8 points [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] for predicting 1-year mortality in previous studies were applied in the present study, the sensitivity and specificity were low, the prognosis was considered to be less accurate. Therefore, a 7-point FRAIL-NH cutoff for 1-year mortality prediction in institutionalized older Japanese patients seems to be the most appropriate.\u003c/p\u003e \u003cp\u003eBuckinx et al [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] and Contreras-Esc\u0026aacute;mez et al [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] reported that the FRAIL-NH scale had no predictive ability for 1-year mortality. In a large cohort study of institutionalized older Japanese patients [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], the 1-year mortality rate was 12.7%, compared to 14.5% reported in the present study. Notably, the patients in the present study were similar to those in a previous study; however, the fact that the participants in the present study were somewhat older and largely residents of special nursing homes with a higher level of nursing care may have affected the results. In the future, it will be necessary to determine the most appropriate cutoff value of the FRAIL-NH scale for Japanese patients using a wider longitudinal study.\u003c/p\u003e \u003cp\u003eThe present study had some limitations. First, although the investigators at each facility were instructed about the contents of the survey items, there were differences among the evaluators. Second, the survey was conducted in a limited area with a small sample size, and it is unclear whether similar results can be obtained for older patients in nursing homes in other areas. Therefore, reproducibility in different populations needs to be verified. However, this is the first multicenter study to determine the predictive validity of the 1-year mortality risk using the FRAIL-NH scale in institutionalized older Japanese patients. In addition, we examined in detail the most effective cutoff value for predicting Japanese-specific mortality using the FRAIL-NH scale in nursing care settings. In the future, it will be necessary to examine the prognostic validity of the FRAIL-NH cutoff value of 7 points after adjusting for confounding factors of mortality in institutionalized older Japanese patients.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe study showed that the FRAIL-NH scale has predictive validity for 1-year mortality rate in institutionalized older Japanese patients. When the FRAIL-NH is used in nursing homes, a cutoff value of 7 points appears to be the best predictor of outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study complied with the Declaration of Helsinki and was approved by the Research Ethics Committee of the Graduate School of Human Life Science, Osaka City University (approval number 21-29). Facility directors consented this study, and an optout process was used to inform residents and their surrogates about our study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analyzed during the present study are not publicly available. Data are available from the corresponding author upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u0026rsquo; contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStudy conception and design: Eri Nishioka and Chika Momoki; Acquisition: Eri Nishioka, Nagomi Ito, Nana Yunoki, Hirokazu Oyamada, Yoko Urata, Harumi Imura, Jun Ookita, Seiko Wada, Masashi Futamata, Sachiyo Kam, Noriko Wajima, Chizuru Takatori, Michiko Tabata, Eri Shibata, Hirotsugu Ishida, Jyunko Masuo; Acquisition, analysis, and interpretation: Eriko Nakata and Chika Momoki; Critical revision: Daiki Habu. All persons designated as authors qualify for authorship, and all authors have been listed. Each author participated sufficiently in the work to take public responsibility for appropriate portions of the manuscript. All the authors have read and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to express our deepest gratitude to all nursing home staff and patients for their cooperation in this research.\u003c/p\u003e\n\u003cp\u003eWe would like to thank Honyaku Center Inc.for English language editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eZhang X, Dou Q, Zhang W, Wang C, Xie X, Yang Y, et al. Frailty as a predictor of all-cause mortality among older nursing home residents: A systematic review and meta-analysis. J Am Med Dir Assoc. 2019;20:657\u0026ndash;e6634.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSatake S, Arai H. The revised Japanese version of the Cardiovascular Health Study criteria (revised J-CHS criteria). Geriatr Gerontol Int Revis Japanese version. 2020;20:992\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSatake S, Senda K, Hong YJ, Miura H, Endo H, Sakurai T, et al. Validity of the Kihon Checklist for assessing frailty status. Geriatr Gerontol Int. 2016;16:709\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaehr E, Visvanathan R, Malmstrom TK, Morley JE. Frailty in nursing homes: The FRAIL-NH Scale. J Am Med Dir Assoc. 2015;16:87\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaehr EW, Pape LC, Malmstrom TK, Morley JE. FRAIL-NH predicts outcomes in long term care. J Nutr Health Aging. 2016;20:192\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVasconcellos Romanini C, Vilas Boas P, Cecato JF, Robello E, Borges MK, Martinelli JE, et al. Prediction of death with the FRAIL-NH in institutionalized older adults: A longitudinal study from a middle-income country. J Nutr Health Aging. 2020;24:817\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiau SJ, Lalic S, Visvanathan R, Dowd LA, Bell JS. The FRAIL-NH scale: Systematic review of the use, validity and adaptations for frailty screening in nursing homes. J Nutr Health Aging. 2021;25:1205\u0026ndash;16.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDevelopment of FRAIL-NH scale Japanese version. Nippon Ronen Igakkai Zasshi Japanese version. 2021;58:164\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiau SJ, Hamada S, Jadczak AD, Sakata N, Lalic S, Tsuchiya-Ito R, et al. Symptomatic and preventive medication use according to age and frailty in Australian and Japanese nursing homes. Aging Clin Exp Res. 2023;35:3047\u0026ndash;57.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiau SJ, Zhao M, Hamada S, Guti\u0026eacute;rrez-Valencia M, Jadczak AD, Li L, et al. Deprescribing opportunities for frail residents of nursing homes: A Multicenter Study in Australia, China, Japan, and Spain. J Am Med Dir Assoc. 2024;25:876\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIto N, Nishioka E, Yunoki N, Momoki C, Oyamada H, Urata Y, et al. Factorscontributing to frailty in institutionalized older adults: A multi-institutional cross-sectionalstudy. Nihon Ronen Igakkai Zasshi. 2024;61:345\u0026ndash;54.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTheou O, Tan CKE, Bell JS, Emery T, Robson L, Morley JE, et al. Frailty levels in residential aged care facilities measured using the frailty index and FRAIL-NH scale. J Am Geriatr Soc. 2016;64:e207\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang M, Zhuo Y, Hu X, Xie L. Predictive validity of two frailty tools for mortality in Chinese nursing home residents: Frailty index based on common laboratory tests (FI-Lab) versus FRAIL-NH. Aging Clin Exp Res. 2018;30:1445\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOkuma R, Fujishima I, Kojima S, Hojo K, Takehara T, Motohashi Y. Development ofa questionnaire to screen dysphagia. Jpn J Dysphagia Rehabil. 2002;6:3\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNakano M, Fujishima I, Ohkuma R, Yoshioka M, Nakae H, Nishigawa K, et al. Examination of the evaluation method of the swallowing questionnaire by scoring. Jpn J Dysphagia Rehabil. 2020;24:240\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRubenstein LZ, Harker JO, Salv\u0026agrave; A, Guigoz Y, Vellas B. Screening for undernutritionin geriatric practice: Developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol Biol Sci Med Sci. 2001;56:M366\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCharlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation. J Chronic Dis. 1987;40:373\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYamada M, Arai H. Long-term care system in Japan. Ann Geriatr Med Res. 2020;24:174\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJapanese Ministry of Health Labor and Welfare. Certification of long-term care need. 2009, Revised April 2024) Authorization Researcher Text. pp. 155\u0026ndash;7 Accessed 2025 Feb 7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hukushi_kaigo/kaigo_koureisha/nintei/index.html\u003c/span\u003e\u003cspan address=\"https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hukushi_kaigo/kaigo_koureisha/nintei/index.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSaijo M, Takeshita A, Matsumoto M, Fukai T, Irie K, Kita K, et al. Relationship between degree of independence in daily activities and denture wearing status of residents of special nursing homes for elderly persons. J Dent Hlth. 2021;71:147\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHonjo Y, Nagai K, Yuri T, Nakai H, Kawasaki I, Harada S, et al. Relationship of the Japanese old stories cognitive scale with the revised Hasegawa cognitive scale and Mini-Mental State Examination. J Appl Gerontol. 2024;43:1668\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChong E, Huang Y, Chan M, Tan HN, Lim WS. Concurrent and predictive validity of FRAIL-NH in hospitalized older persons: An exploratory study. J Am Med Dir Assoc. 2021;22:1664\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTheou O, Sluggett JK, Bell JS, Lalic S, Cooper T, Robson L, et al. Frailty, hospitalization, and mortality in residential aged care. J Gerontol Biol Sci Med Sci. 2018;73:1090\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDe Silva TR, Theou O, Vellas B, Cesari M, Visvanathan R. Frailty screening (FRAIL-NH) and mortality in French nursing homes: Results from the incidence of pneumonia and related consequences in nursing home residents study. J Am Med Dir Assoc. 2018;19:411\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLuo H, Lum TYS, Wong GHY, Kwan JSK, Tang JYM, Chi I. Predicting adverse health outcomes in nursing homes: A 9-year longitudinal study and development of the FRAIL-minimum data set (MDS) quick screening tool. J Am Med Dir Assoc. 2015;16:1042\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGe F, Liu W, Liu M, Tang S, Lu Y, Hou T. Accessing the discriminatory performance of FRAIL-NH in two-class and three-class frailty and examining its agreement with the frailty index among nursing home residents in mainland China. BMC Geriatr. 2019;19:296.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuckinx F, Croisier JL, Reginster JY, Lenaerts C, Brunois T, Rygaert X, et al. Prediction of the incidence of falls and deaths among elderly nursing home residents: The SENIOR study. J Am Med Dir Assoc. 2018;19:18\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eContreras-Esc\u0026aacute;mez B, Izquierdo M, Galbete Jim\u0026eacute;nez A, Guti\u0026eacute;rrez-Valencia M, Cedeno-Veloz BA, Mart\u0026iacute;nez-Velilla N. Differences in the predictive capability for functional impairment, cognitive decline and mortality of different frailty tools: A longitudinal cohort study. Med Clin (Barc). 2020;155:18\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNakazawa A, Nakamura K, Kitamura K, Yoshizawa Y. Association between body mass index and mortality among institutionalized elderly adults in Japan. Environ Health Prev Med. 2013;18:502\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 to 4 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"nursing homes, frailty, ROC curve, mortality, FRAIL-NH","lastPublishedDoi":"10.21203/rs.3.rs-5978015/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5978015/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe present study aimed to investigate the predictive ability of the FRAIL-NH scale for 1-year mortality in institutionalized older Japanese patients and the determine the cutoff value.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis prospective \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eobservational\u003c/span\u003e study used data from the KITAKAWACHI study, which commenced in October 2021. The analysis included baseline data from September 2021 to January 2022 and 1-year follow-up data from September 2022 to January 2023. In total, 227 institutionalized older patients were included in the analysis, with those who died within 1 year categorized into the Died group and the other patients included in the Alive group. Receiver operating characteristic analysis was used to examine the ability and cut-off value of FRAIL-NH for predicting 1-year mortality.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThirty-three patients (14.5%) died within 1 year, and there were significantly more patients with a high level of nursing care, low body mass index, lower calf circumference, malnutrition, and dysphagia. In addition, there were 117 (51.5%) cases of frailty, and the mortality rate was significantly higher in the Died group than that in the Alive group based on the FRAIL-NH score (8.0 [7.0, 9.5] vs. 5.0 [2.0, 7.0]) and all components, except illness, and the percentage of frailties. Furthermore, receiver operating characteristics analysis for 1-year mortality yielded an area under the curve (95% confidence interval) of 0.806 (0.729\u0026ndash;0.883) and a cutoff value of 6.5 points for the FRAIL-NH based on the Youden's index. The sensitivity, specificity, false-positive rate, false-negative rate, and accuracy of the 7-point cutoff (the approximated value of the 6.5-point cutoff) were 84.8%, 70.6%, 15.2%, 29.4%, and 72.7%, respectively, which were more balanced in sensitivity and specificity than the 6- and 8-point cutoffs reported in previous studies, with intermediate false-positive rate, false-negative rate, and accuracy.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe FRAIL-NH scale predicted the risk of 1-year mortality in institutionalized older Japanese adults. When FRAIL-NH was used in nursing homes, a cutoff value of 7 points appeared to be the best predictor of outcomes. These findings highlight the critical role of early frailty screening in improving patient care and decision-making in geriatric care settings.\u003c/p\u003e","manuscriptTitle":"Prognostic ability of FRAIL-NH for mortality in institutionalized older Japanese adults: a 1-year prospective observational study of the KITAKAWACHI study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-18 14:26:52","doi":"10.21203/rs.3.rs-5978015/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b31b5c41-0ef6-4197-9835-41c1f68e904d","owner":[],"postedDate":"February 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-10T09:41:08+00:00","versionOfRecord":[],"versionCreatedAt":"2025-02-18 14:26:52","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5978015","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5978015","identity":"rs-5978015","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}